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Talazoparib + Enzalutamide Tied to Improved Overall Survival in Metastatic Prostate Cancer

For patients with metastatic castration-resistant prostate cancer (mCRPC) unselected for homologous recombination repair (HRR) gene alterations, talazoparib (TALA) + enzalutamide (ENZA) is associated with improved overall survival versus placebo + ENZA, according to a study presented at the American Society of Clinical Oncology annual Genitourinary Cancers Symposium, held from Feb. 13 to 15 in San Francisco.

Neeraj Agarwal, M.D., from the Huntsman Cancer Institute at the University of Utah in Salt Lake City, and colleagues reported final overall survival (OS) data among patients with mCRPC unselected for HRR gene alterations who had improved radiographic progression-free survival with TALA + ENZA versus placebo + ENZA as first-line treatment in the phase 3 TALAPRO-2 trial.

A total of 805 patients were randomly assigned: 402 and 403 to TALA + ENZA and placebo + ENZA, respectively. At the data cutoff (Sept. 3, 2024), 52 and 60 percent of patients in the TALA + ENZA and placebo + ENZA arms, respectively, had died. The researchers found that the hazard ratio for OS was 0.796 (95 percent confidence interval, 0.661 to 0.958) for TALA + ENZA versus placebo + ENZA, with a median OS of 45.8 and 37.0 months, respectively. In patients who were HRR-deficient and in those who were HRR-nondeficient/unknown, OS favored TALA + ENZA versus placebo + ENZA (hazard ratios, 0.549 [95 percent confidence interval, 0.364 to 0.826] and 0.878 [95 percent confidence interval, 0.713 to 1.080], respectively). Updated radiographic progression-free survival data favored TALA + ENZA versus placebo + ENZA, consistent with the primary analysis (hazard ratio, 0.667; 95 percent confidence interval, 0.551 to 0.807).

"TALA + ENZA demonstrated a statistically significant and clinically meaningful improvement in OS versus standard-of-care ENZA," the authors write.

Several authors disclosed ties to Pfizer, which manufactures talazoparib.

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Dual-Targeted Therapies Plus Chemo Improve Objective Response Rate in BRAF V600E Metastatic CRC

For patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC), encorafenib + cetuximab (EC) plus standard chemotherapy (modified folinic acid [or levofolinate], fluorouracil, and oxaliplatin regimen [mFOLFOX6]) is associated with an improved objective response rate compared with standard of care (SOC), according to a study published online Jan. 25 in Nature Medicine. The research was published to coincide with the American Society of Clinical Oncology annual Gastrointestinal Cancers Symposium, held from Jan. 23 to 25 in San Francisco.

Scott Kopetz, M.D., Ph.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues examined EC+mFOLFOX6 versus SOC in patients with previously untreated BRAF V600E mCRC in the phase 3 BREAKWATER study.

At data cutoff, data were not mature for the dual primary end point of progression-free survival. However, the researchers found that BREAKWATER met the other dual primary end point of objective response rate, demonstrating a significant and clinically relevant improvement (60.9 versus 40.0 percent for EC+mFOLFOX6 versus SOC; odds ratio, 2.443). The median duration of response was 13.9 and 11.1 months, respectively. The hazard ratio was 0.47 at this first interim analysis of overall survival. The safety profiles were consistent with those known for each agent; serious adverse event rates were 37.7 and 34.6 percent in the EC+mFOLFOX6 and SOC groups, respectively.

"These encouraging data support this regimen to potentially become the new SOC in BRAF V600E-mutant mCRC; prespecified analyses of mature progression-free survival and overall survival data are planned," the authors write.

Several authors disclosed ties to biopharmaceutical companies, including Pfizer, which sponsored BREAKWATER; support was also received from other pharmaceutical companies.

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GLP-1 Receptor Agonists Tied to Risks and Benefits Beyond Weight Loss

For people with diabetes, the use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) is associated with a reduced risk for certain disorders and conditions, including neurocognitive and cardiometabolic disorders, and with an increased risk for others, including gastrointestinal and arthritic disorders, according to a study published online Jan. 20 in Nature Medicine.

Yan Xie, from the VA St. Louis Health Care System, and colleagues examined the effectiveness and risks for GLP-1 RAs. The authors used the U.S. Department of Veterans Affairs databases to build a cohort of people with diabetes who initiated a GLP-1 RA and compared them to patients initiating sulfonylureas, dipeptidyl peptidase 4 (DPP4) inhibitors, or sodium-glucose cotransporter-2 (SGLT2) inhibitors (215,970, 159,465, 117,989, and 258,614 individuals, respectively). They were also compared to a control group composed of equal proportions of individuals initiating sulfonylureas, DPP4 inhibitors, and SGLT2 inhibitors (536,068 people), as well as a control group that continued use of non-GLP-1 RA antihyperglycemics (usual care; 1,203,097 individuals). The associations of GLP-1 RA use with each comparator were examined for 175 health outcomes.

The researchers found that GLP-1 RA use compared with usual care was associated with a reduced risk for substance use and psychotic disorders, seizures, neurocognitive disorders (including Alzheimer disease and dementia), coagulation disorders, cardiometabolic disorders, infectious illnesses, and several respiratory conditions. Conversely, GLP-1 RA use was associated with an increased risk for gastrointestinal disorders, hypertension, syncope, arthritic disorders, nephrolithiasis, interstitial nephritis, and drug-induced pancreatitis compared with usual care.

"Our discovery approach confirms previous studies and clinical trials and also uncovers previously unreported benefits and risks of GLP-1 RAs," the authors write. "The results may be useful for informing clinical care."

Two authors disclosed ties to Pfizer.

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AAP Provides Guidance on Pediatric Fracture Diagnosis, Abuse Assessment

In an American Academy of Pediatrics clinical report published online Jan. 21 in Pediatrics, guidance is presented for the diagnosis of pediatric fractures and assessment of suspected child abuse.

Suzanne Haney, M.D., from the University of Nebraska Medical Center in Omaha, and colleagues reviewed recent advances in the understanding of fracture specificity, fracture mechanisms, and other medical conditions that predispose infants and children to fracture and developed guidelines for evidence-based diagnosis and appropriate evaluations when assessing fractures in children.

The authors note that fractures in a nonambulatory child, fractures that are not consistent with the history provided or for which no history of injury is given, and fractures that have a high or moderate specificity for abuse are more concerning for abuse. For children in whom abuse is suspected, a close examination of all areas of skin to look for other injuries is important. Medical history and family history are important to assess for prior injuries, fracture, or medical conditions predisposing children to fracture. Follow-up imaging is recommended and laboratory evaluation is important. Suspected abusive fractures should be reported to authorities based on reasonable concern/suspicion for abuse and subject to state statutes. Bias exists in the diagnosis and reporting of child abuse; providers should be aware of this bias and try to limit its effects.

"Optimal assessment of the child with fractures and suspected child abuse requires careful review of the clinical history, a thorough physical examination, rigorous imaging evaluation, and correlation with bone health laboratory studies," the authors write.

One author disclosed ties to BioMarin, Pfizer, Catalyst, and Alexion.

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FDA Adds Warning Label to RSV Vaccines Abrysvo and Arexvy

The U.S. Food and Drug Administration now requires and has approved safety labeling changes to the prescribing information for the Abrysvo (Pfizer) and Arexvy (GlaxoSmithKline) respiratory syncytial virus (RSV) vaccines to include warnings and precautions about the risk for Guillain-Barré syndrome (GBS).

For each vaccine, postmarketing observational studies suggest an increased risk of GBS during the 42 days following vaccination.

Arexvy has been approved for the prevention of lower respiratory tract disease caused by RSV in all individuals 60 years of age and older and for those aged 50 to 59 years at increased risk. Abrysvo has been approved for the prevention of lower respiratory tract disease caused by RSV in all individuals 60 years of age and older, as well as individuals aged 18 to 59 years at increased risk. Abrysvo is also approved for pregnant individuals at 32 through 36 weeks of gestational age for the prevention of lower respiratory tract disease caused by RSV in infants from birth through 6 months of age.

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Eight in 10 Infants Received RSV Protection in the 2023 to 2024 Season

Eight in 10 infants received respiratory syncytial virus (RSV) protection during the 2023 to 2024 season, according to a research letter published online Jan. 8 in JAMA Network Open.

Karen B. Jacobson, M.D., M.P.H., from Kaiser Permanente Northern California in Oakland, and colleagues investigated uptake of RSVpreF among pregnant women at 32 to 36 weeks of gestation and nirsevimab among infants aged younger than 8 months, as well as sociodemographic factors associated with uptake within the early period of availability. The analysis included electronic medical record data among 17,251 infants born to mothers aged 15 to 49 years in a single health system between Oct. 17, 2023 (when nirsevimab became available; RSVpreF became available October 25), and March 31, 2024.

The researchers found that 33.9 percent of infants were exposed to only the maternal RSVpreF vaccine, at a median gestational age of 34.0 weeks, while 40.9 percent of infants received only nirsevimab (median age, 4 days). Only 2.7 percent of infants were exposed to both maternal RSVpreF and nirsevimab, and of these, 31.1 percent were born preterm and 24.1 percent were admitted to the neonatal intensive care unit. Infants of mothers younger than 25 years were less likely than infants of mothers 35 years and older to receive only RSVpreF (26.4 versus 37.9 percent), but thy were more likely to receive only nirsevimab (44.2 versus 40.1 percent). Infants of Asian mothers had the highest exposure to RSVpreF and/or nirsevimab (86.7 percent), while infants of Black mothers had the lowest exposure (70.2 percent).

"The availability of two different RSV protection methods in sufficient supply may have contributed to an increased proportion of infants protected against RSV, which may help mitigate disparities," the authors write.

Several authors disclosed ties to pharmaceutical companies, including Pfizer, which manufactures the RSVpreF vaccine, and Sanofi, which manufactures nirsevimab.

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Age Impacts Surgical Outcomes for Breast Reconstruction

For patients undergoing breast reconstruction after mastectomy, age impacts surgical outcomes, with older age negatively correlated with the Satisfaction with Breasts domain of the BREAST-Q, but positively correlated with Psychosocial Well-Being, according to a study published in the January issue of Plastic and Reconstructive Surgery.

Minji Kim, from the Memorial Sloan Kettering Cancer Center in New York City, and colleagues conducted a retrospective analysis of patients who underwent autologous (ABR) or implant-based breast reconstruction (IBR) after mastectomy to examine the impact of age on complications and patient-reported outcomes (PROs) measured preoperatively, at six months, and at one to five years postoperatively.

The study included 4,730 patients: 32.5 and 67.5 percent underwent ABR and IBR, respectively. The researchers observed a significant association for older age with an increased risk for developing mastectomy skin flap/nipple necrosis, infection, and seroma. A negative correlation was seen for older age with the Satisfaction with Breasts domain of the BREAST-Q, while a positive correlation was seen with the Psychosocial Well-Being domain. There was no correlation observed for older age with the Physical Well-Being of the Chest or Sexual Well-Being domains. Different complications and PRO profiles were seen in subgroup analyses of ABR and IBR patients.

"Older patients should be informed about the potential associated risks and anticipated PROs," the authors write. "Surgeons and patients can also use our findings to optimize older patients' postoperative satisfaction."

Authors disclosed ties to RTI Surgical, MirrorMe3D, Pfizer, Regeneron, Atyr, Integra, and PureTech.

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High Acceptance Seen for Liver Stiffness Test With Routine Retina Scan in T2DM

For individuals with type 2 diabetes, examination with vibration-controlled transient elastography (VCTE) alongside retina scanning has a high acceptance rate, but false-positive findings seem to be common, according to a study published online Dec. 12 in The Lancet Gastroenterology & Hepatology.

Andrea Lindfors, M.D., from the Karolinska University Hospital in Stockholm, and colleagues conducted a cross-sectional study in which people with type 2 diabetes referred to routine retina scanning were offered VCTE. Participants with a liver stiffness measurement of at least 8.0 kPa or those with unreliable measurements were referred for a secondary evaluation, which included follow-up VTCE.

Overall, 1,005 of 1,301 participants who were eligible for assessment with VCTE (77.2 percent) accepted assessment. The researchers found that 973 participants (96.8 percent) had complete measurements, and of these, 504 (51.8 percent) had controlled attenuation parameter values of 280 dB/m or higher, indicative of metabolic dysfunction-associated steatotic liver disease. Reliable liver stiffness measurements were available for 977 participants; 154 (15.8 percent) had values of at least 8.0 kPa and 49 (5.0 percent) had values higher than 12.0 kPa, suggestive of liver fibrosis and possible advanced fibrosis, respectively. Upon reassessment with a second VCTE after referral, 45.2 percent of 124 individuals had values less than 8.0 kPa. Overall, 7.4 and 2.9 percent of 1,005 participants had a final liver stiffness of at least 8.0 kPa and greater than 12.0 kPa, respectively.

"A high proportion of participants with an initial elevated liver stiffness measurement with VCTE did not have elevated liver stiffness measurements at the second visit," the authors write. "This risk must be considered if implementing this method into clinical routine."

One author disclosed ties to pharmaceutical companies, including Pfizer and Gilead, which funded the study.

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RSVpreF Vaccine Effective in Preventing Severe RSV in Older Adults

Respiratory Syncytial Virus Prefusion F (RSVpreF) vaccination is effective against RSV-related lower respiratory tract disease (LRTD) among adults aged 60 years or older, according to a study published online Dec. 13 in JAMA Network Open.

Sara Y. Tartof, Ph.D., M.P.H., from Kaiser Permanente Southern California in Pasadena, and colleagues estimated RSVpreF vaccine effectiveness in older adults in a retrospective case-control study. Cases were adults aged 60 years or older (mean age, 76.8 years) with hospitalizations or emergency department visits for LRTD from Nov. 24, 2023, to April 9, 2024, who had respiratory swabs collected and tested for RSV.

The study included 7,047 LRTD-related hospitalizations or emergency department encounters with RSV testing results. Overall, 14.2 percent were immunocompromised and 93.3 percent had one or more Charlson comorbidity. The estimated adjusted vaccine effectiveness was 91 percent using a strict control definition that included RSV-negative LRTD events that were negative for human metapneumovirus, severe acute respiratory syndrome coronavirus 2, and influenza and positive for a non-vaccine-preventable cause. Estimated adjusted vaccine effectiveness was 90 percent using a broad control definition, including all RSV-negative LRTD events.

"Based on our study results and RSV incidence in older adults, for approximately every 250 persons vaccinated, one RSV-related emergency department or hospitalization encounter could be prevented in the first season after vaccination," the authors write. "These data suggest use of RSVpreF in older adults, providing an opportunity to reduce severe medically attended RSV disease burden."

Several authors disclosed ties to biopharmaceutical companies, including Pfizer, which manufactures the RSVpreF vaccine and funded the study.

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Air Pollution Exposure Throughout Pregnancy Ups Risk for Spontaneous Preterm Birth

Exposures to fine particulate matter (PM2.5) and specific PM2.5 constituents during pregnancy is associated with increased odds of spontaneous preterm birth (sPTB), according to a study published online Nov. 13 in JAMA Network Open.

Anqi Jiao, from the University of California Irvine, and colleagues examined whether exposure to PM2.5 and its constituents are associated with sPTB. The analysis included 409,037 births in Southern California (2008 to 2018).

The researchers found positive associations of PM2.5, black carbon, nitrate, and sulfate with sPTB. Per interquartile range increase, odds of sPTB were 15 percent higher for PM2.5, 15 percent higher for black carbon, 9 percent higher for nitrate, and 6 percent higher for sulfate during the entire pregnancy. The most susceptible window was exposure during the second trimester. Among individuals with lower educational attainment, risk was even higher. Additionally, environmental exposures increased risk (e.g., those who were exposed to limited green space, more wildfire smoke, or extreme heat).

"Though the causes of spontaneous preterm birth are complex and not fully understood, our study identifies air pollution as a contributing factor, highlighting the need for targeted interventions," coauthor Jun Wu, Ph.D., also from the University of California Irvine, said in a statement.

Two authors disclosed ties to Pfizer, Dynavax Technologies, and/or Hologic.

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Study Assesses Risk for 28-Day Hospitalization for Adults With RSV

A number of adults with outpatient medically attended respiratory syncytial virus (MA-RSV) infection experience hospitalization within 28 days, with a higher proportion among high-risk subgroups, according to a study published online Nov. 19 in JAMA Network Open.

Suzanne N. Landi, Ph.D., M.P.H., from Pfizer Inc. in New York City, and colleagues examined the absolute risk for 28-day all-cause hospitalization following outpatient MA-RSV infection in adults in a cohort study using data from three databases (the Optum deidentified Integrated Claims-Clinical dataset, TriNetX Linked, and Veradigm Network Electronic Health Record [VNEHR] database linked with claims). Data were analyzed across six RSV years from Oct. 1, 2016, to Sept. 30, 2022. The main outcome was all-cause 28-day hospitalization among all adults and a high-risk subgroup (with asthma, chronic obstructive pulmonary disease [COPD], congestive heart failure [CHF], or age 65 years and older).

The analyses included 67,239 MA-RSV infections (2,771 from Optum, 7,442 from TriNetX, and 57,026 from VNEHR). The prevalence of comorbidity was 20.0 to 30.5 percent for COPD, 14.6 to 24.4 percent for CHF, and 30.0 to 34.4 percent for asthma. Individuals aged 65 years and older accounted for 14.0 to 54.5 percent of the participants. The researchers found that 6.2, 6.0, and 4.5 percent were hospitalized in Optum, TriNetX, and VNEHR, respectively. In the high-risk subgroup, the corresponding proportions were 7.6, 8.5, and 6.5 percent, respectively.

"These results highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations," the authors write.

Several authors disclosed ties to pharmaceutical companies, including Pfizer, which funded the study.

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Supply Chain Issues Less Likely to Yield Drug Shortages in Canada Versus U.S.

Drug-related reports of supply chain issues are less likely to result in drug shortages in Canada than in the United States, according to a study published online Oct. 31 in the Journal of the American Medical Association.

Mina Tadrous, Pharm.D., Ph.D., from the University of Toronto, and colleagues compared how frequently reports of drug-related supply chain issues in the United States versus Canada were associated with drug shortages in a longitudinal cross-sectional study.

The researchers found that 49.0 and 34.0 percent of the 104 drug-related reports of supply chain issues in both countries were associated with drug shortages in the United States versus Canada (adjusted hazard ratio, 0.53). The lower risk for drug shortages in Canada versus the United States was consistent before and after the COVID-19 pandemic (adjusted hazard ratios, 0.47 and 0.31, respectively). The shortage risk was double for sole-sourced drugs and almost half for Canadian tier 3 medicines (adjusted hazard ratios, 2.58 and 0.56, respectively) after combining reports of supply chain issues in both countries.

"These findings highlight the need for international cooperation between countries to curb the effects of drug shortages and improve resiliency of the supply chain for drugs," the authors write.

One author disclosed ties to Pfizer and Bristol Myers Squibb.

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Biden Administration Uses Wartime Powers to Help Restart IV Fluid Plant in North Carolina

Following hurricane damage that shuttered a North Carolina plant that makes 60% of the country's IV fluids, U.S. health officials have invoked the Defense Production Act to hasten rebuilding of the factory.

A nationwide shortage of IV fluids has only worsened since Hurricane Helene wrecked the plant run by Baxter International Inc. late last month, and hospitals say they are still postponing surgeries and procedures due to short supply.

"Ensuring people have medical supplies they need is a top priority of the [Biden] Administration. It's exactly why we are working closely with Baxter to support cleanup and restoration of the facility, including invoking the Defense Production Act to help production resume as quickly as possible," an official with the U.S. Department of Health and Human Services told CBS News on Tuesday. Last week, the agency detailed its plans to help reopen the factory.

While the North Carolina factory remains closed, the U.S. Food and Drug Administration has allowed Baxter to import IV fluids from its other plants around the world. Officials say they are also backing plans to airlift more supplies into the United States.

In recent weeks, U.S. health officials have urged all hospitals to conserve IV fluids, even if they are not facing a supply crunch. Some major health systems have told CBS News that they had avoided a shortfall, but were still carefully managing IV supplies.

Meanwhile, the Veterans Health Administration, which operates the country's largest integrated health system, said it is monitoring the situation.

"VA is closely tracking inventory, shipments, cross-leveling supply between facilities when appropriate, and following general conservation guidance to maximum use of existing supplies," Veterans Affairs Deputy Assistant Secretary Terrence Hayes said in a statement Tuesday.

This is not the first time the Defense Production Act has been deployed to help manage critical medical supply shortages: It was used by both the Trump and Biden administrations to boost manufacturing of test swabs, ventilators and vaccines during the pandemic.

IV fluids are needed for the care of patients such as premature babies, people on dialysis and frail individuals who rely on IV feeding.

Baxter would not say when it expected its North Carolina plant to become fully operational again, but said it hoped to resume production in phases by the end of the year.

A bridge near the plant is being prioritized for repair so that trucks already loaded with Baxter product can leave and distribute supplies not damaged by the storm, the New York Times reported.

“We will spare no resource -- human or financial -- to restart operations and help ensure patients and providers have the products they need,” Baxter CEO José Almeida said in an Oct. 9 statement.

Hospitals across the nation need IV fluids to hydrate and feed patients, including those battling a life-threatening blood infection known as sepsis.

“When you’re coming in with sepsis, and specifically the septic shock, those one-liter bags are the most immediate form of treatments, and sometimes you’re getting two, if not three, of them in rapid succession,” Dr. Chris DeRienzo, chief physician executive of the American Hospital Association, explained to the Times. “There are so many special populations impacted by the shortage, what it really leads to is an impact on the whole population.”

IV fluids are also essential to the care of people in dialysis, because patients need specially formulated liquids to help clean their blood once kidneys begin to fail.

The North Carolina plant was a major supplier of such fluids, William Poirier, of the Renal Healthcare Association, told the Times.

The suddenness of the IV fluid crisis highlights ongoing concerns about the fragility of the supply chain of essential medical supplies in the United States. Experts have long noted that the manufacture and distribution of certain items is concentrated in only a few companies.

The pandemic revealed many vulnerabilities, as officials scrambled to find essential supplies of masks, gloves and ventilators. In 2023, tornado damage to a Pfizer plant in North Carolina sparked a frenzied search for new supplies of certain generic drugs.

Most of the products involved in these shortages are low-cost, low-profit items with few incentives for new manufacturers to enter into production, experts explained.

Whether government is doing enough to build capacity is uncertain, Tom Cotter, executive director of Healthcare Ready, a nonprofit founded after Hurricane Katrina, told the Times.

“We haven’t seen a really big uptick in investment in resiliency from the government to harden our supply chains,” Cotter said. “Storms are reaching areas where they’ve never been before with greater severity. There is an increased need to widen the scope of what we think is vulnerable in our medical supply chain.”

More information

Find out more about IV fluids and what they are used for at the Cleveland Clinic.

SOURCES: Statements, Baxter International, U.S. Department of Health and Human Services; CBS News; New York Times

Risk for Most Cardiovascular Events Reduced After COVID-19 Vaccination

COVID-19 vaccination is associated with a reduced risk for most cardiovascular events, but with slightly increased risks of extrasystoles and transient ischemic attack, as well as myocarditis and pericarditis after mRNA vaccination, according to a study published online Sept. 30 in the European Heart Journal.

Yiyi Xu, Ph.D., from the University of Gothenburg in Sweden, and colleagues examined the risks for several cardiovascular and cerebrovascular events in a nationwide register-based cohort (8,070,674 Swedish adults). The postvaccination risk for myocarditis/pericarditis, dysrhythmias, heart failure, myocardial infarction, and cerebrovascular events (transient ischemic attack and stroke) was examined in several risk windows after each vaccine dose.

The researchers found reduced risks for cardiovascular events postvaccination for most of the studied outcomes, especially after dose 3 (hazard ratios ranging from 0.69 to 0.81), while the risks for myocarditis and pericarditis were increased one to two weeks after COVID-19 mRNA vaccination. Across vaccines, similar slightly increased risks were seen for extrasystoles (hazard ratios, 1.17 and 1.22 for doses 1 and 2, respectively, which were stronger in the elderly and males), but not for arrhythmias, and for transient ischemic attack (hazard ratio, 1.13, mainly in elderly), but not for stroke.

"We found decreased risks of several serious cardiovascular outcomes after COVID-19 vaccination, likely related to the protection of vaccination against severe COVID-19," the authors write. "Overall, our results clearly underscore the protective benefits of complete vaccination, especially for elderlies."

Several authors disclosed ties to pharmaceutical companies, including AstraZeneca and Pfizer.

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IV Fluid Plant in Florida Remains Functional After Milton

Facing a nationwide shortage of vital IV fluids after Hurricane Helene knocked out a North Carolina production plant, officials heaved a sigh of relief at the news that a second plant in Daytona Beach, Fla., was spared by Hurricane Milton and remains functional.

According to the New York Times, a spokeswoman for B. Braun, the company that runs the Daytona Beach plant, said the facility remained intact and would reopen on Friday.

Between them, the North Carolina and Florida plants produce 60% and 25%, respectively, of the IV fluids that many patients in hospitals and dialysis centers need to survive.

With supplies already crippled by the closure of Baxter's Marion, NC, plant after Helene, the closure of the B. Braun facility would have been devastating, experts said.

IV fluids are needed for the care of patients such as premature babies, people on dialysis and frail individuals who rely on IV feeding.

Hospitals across the United States are already postponing surgeries and rationing IV fluids as shortages take hold, the Times said.

Hannah Hale, 37, lives near Dallas and for eight years has required IV feeding with a concentrated dextrose solution, after Crohn's disease led to surgeries that impaired her digestive tract.

Her specialized pharmacy told her on Monday it cannot find enough of the IV solution to replenish her supply.

“They’re not supposed to just drop me like that,” she told the Times, adding that calls to 14 other pharmacies failed to find a new supplier.

“I don’t have any recourse," Hale said.

Anticipating Milton, B. Braun had told the Times that on Tuesday it had loaded trucks headed north full of products, to get them to a safer location.

At Baxter, staff have been working overtime to help patch together new supply chains, increasing production at plants located overseas.

On Wednesday, the U.S. Food and Drug Administration (FDA) said that it was authorizing imports of IV products from Baxter plants in Canada, Ireland, the United Kingdom and China.

Baxter had been forced to limit supplies to hospitals to 40% of usual following the damage to its plant by Helene, but the company told the Times that deliveries would have already risen to about 60% of usual by Wednesday of this week.

Baxter would not say when it expected its Marion plant to become fully operational again, but said it hoped to resume production in phases by the end of the year.

A bridge near the plant is being prioritized for repair so that trucks already loaded with Baxter product can leave and distribute supplies not damaged by the storm, the Times said.

“We will spare no resource -- human or financial -- to restart operations and help ensure patients and providers have the products they need,” José Almeida, the chief executive at Baxter, said in a statement Wednesday.

Hospitals across the nation need IV fluids to hydrate and feed patients, including those battling a life-threatening blood infection known as sepsis.

“When you’re coming in with sepsis, and specifically the septic shock, those one-liter bags are the most immediate form of treatments, and sometimes you’re getting two, if not three, of them in rapid succession,” Dr. Chris DeRienzo, chief physician executive of the American Hospital Association, explained to the Times. “There are so many special populations impacted by the shortage, what it really leads to is an impact on the whole population.”

IV fluids made by Baxter and B. Braun are also essential to the care of people in dialysis, because patients need specially formulated liquids to help clean their blood once kidneys begin to fail.

The Marion plant was a major supplier of such fluids, William Poirier of the Renal Healthcare Association told the Times.

Responding to the crisis, Xavier Becerra, secretary of the Health and Human Services Department, said in a letter to health care providers posted Wednesday that his agency was doing all it can. HHS was working with Baxter closely to help minimize disruptions in supply, he said.

“My department commits to mitigating the impact of Hurricane Helene and doing all we can to prevent further disruption as a result of Hurricane Milton,” the letter from Becerra said.

The suddenness of the IV fluid crisis highlights ongoing concerns about the fragility of the supply chain of essential medical supplies in the United States. Experts have long noted that the manufacture and distribution of certain items is concentrated in only a few companies.

The COVID pandemic revealed many vulnerabilities, as officials scrambled to find essential supplies of masks, gloves and ventilators. In 2023, tornado damage to a Pfizer plant in North Carolina sparked a frenzied search for new supplies of certain generic drugs.

Most of the products involved in these shortages are low-cost, low-profit items with few incentives for new manufacturers to enter into production, experts explained.

Whether government is doing enough to build capacity is uncertain, Tom Cotter, executive director of Healthcare Ready, a nonprofit founded after Hurricane Katrina, told the Times.

“We haven’t seen a really big uptick in investment in resiliency from the government to harden our supply chains,” Cotter said. “Storms are reaching areas where they’ve never been before with greater severity. There is an increased need to widen the scope of what we think is vulnerable in our medical supply chain.”

More information

Find out more about IV fluids and what they are used for at the Cleveland Clinic.

SOURCES: Statements, Baxter International, U.S. Department of Health and Human Services and the U.S. Food and Drug Administration; The New York Times

U.S. Scrambles to Find Hospital IV Fluids After Helene Damages NC Plant

After Hurricane Helene knocked out a North Carolina production plant for a major supplier of IV fluids for U.S. hospitals, officials said the federal government is reaching out internationally to help restore supply.

The situation could get even worse: As Hurricane Milton barreled down on Florida, a second IV fluid maker's facility in Daytona Beach was in its crosshairs, the New York Times reported.

Together, the Baxter plant in Marion, N.C., and the B. Braun plant in Daytona Beach manufacture about 60% and 25%, respectively, of the nation's supply of IV fluids. These fluids are needed for the care of patients such as premature babies, people on dialysis and frail individuals who rely on IV feeding.

Hospitals across the United States are already postponing surgeries and rationing IV fluids as shortages take hold, the Times said.

Hannah Hale, 37, lives near Dallas and for eight years has required IV feeding with a concentrated dextrose solution, after Crohn's disease led to surgeries that impaired her digestive tract.

Her specialized pharmacy told her on Monday it cannot find enough of the IV solution to replenish her supply.

“They’re not supposed to just drop me like that,” she told the Times, adding that calls to 14 other pharmacies failed to find a new supplier.

“I don’t have any recourse," Hale said.

Suppliers Baxter and B. Braun have said they are doing all they can to redirect new sources from elsewhere.

Anticipating Milton, B. Braun told the Times that on Tuesday it had loaded trucks headed north full of products, to get them to a safer location.